Kornimate/medical-research-clean huggingface dataset:
supersaturated oxygen comprehensive observational registry

Conditions: STEMI - ST Elevation Myocardial Infarction; AMI

Summary: the supersaturated oxygen comprehensive observational registry (sscore) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of supersaturated oxygen (sso2) therapy versus percutaneous coronary intervention (pci) alone among patients with anterior acute myocardial infarction (ami) in routine clinical practice. the goal is to collect real-world data from patients treated with sso2 therapy to determine its impact on the overall heart failure (hf) burden on patients and healthcare systems compared with usual care for treatment of patients with ami. the sscore registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.


Eligibility criteria:
inclusion criteria subjects screened for either the prospective control cohort or the sso2 treated (on-label or all others) cohorts must meet all the following baseline criteria: * men or women aged 18 years or older * presentation with ami and successful revascularization of the infarct-related artery with pci * the subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate institutional review board (irb) treatment with sso2 therapy will be up to the physician's discretion and the decision will be made prior to enrollment in the study. any subject that is treated with sso2 therapy and meets the baseline criteria should be invited to participate in the study. subjects who are in the prospective control cohort as well as subjects enrolled in the sso2 treated on-label cohort must meet these additional criteria: * the primary culprit lesion must be in the left anterior descending (lad) coronary tree * successful primary pci within 6 hours of symptom onset, as documented by \<50% diameter residual angiographic stenosis and thrombolysis in myocardial infarction (timi) grades 2 or 3 flow in the target vessel * no major complications such as perforation, serious bleeding, or cardiogenic shock * not pregnant or nursing exclusion criteria * subjects will be excluded if they meet any of the following criteria: * life expectancy of less than 2 years * no access to medical records from either the index hospitalization or subsequent outpatient visits * currently participating in an investigational drug or device trial
oocyte recipient's decision in the number of embryos to be transferred

Conditions: Decision Making; Infertility, Female; Counseling

Summary: multiple pregnancies are considered an art complication. the only effective way to reduce its incidence is to transfer a single embryo. nonetheless, there is some reluctance among the patients to accept this strategy. in ivf/icsi programs, it has been demonstrated that, after receiving the information about the similar cumulative live birth rate after single embryo transfer (set) and double embryo transfer (det) and the obstetric and perinatal risks of multiple pregnancy, a significant number of patients opt for set. up to date, no comparable studies have been published in oocyte recipients. the aim of this study is to evaluate if the information given to the patients influence their preference on the number of embryos to be transferred. it also seeks to identify factors which determine the initial preference and factors which can explain a hypothetic change in this preference.


Eligibility criteria:
inclusion criteria: * patients under their first oocyte or embryo donation cycle. * sufficient knowledge of spanish to fill out questionnaires. exclusion criteria: * patients with a medical indication for single embryo transfer (e.g. turner syndrome, uterine surgeries, cardiovascular risk). * having had previous oocyte or embryo donation cycles. * insufficient knowledge of spanish.

Keywords: oocyte donation recipient counselling single embryo transfer (set) double embryo transfer (det) decision-making
phase 3 study to evaluate the efficacy and safety of omega-3-acids ethylesters 90 in type ⅱb hyperlipidemia

Conditions: Hyperlipidemia, Familial Combined

Summary: the purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/atorvastatin calcium in type ⅱb hyperlipidemia


Eligibility criteria:
inclusion criteria: * ldl≥160mg/dl, 200mg/dl≤tg\<500mg/dl * in the case of smokers, he agrees should be smoke-free * in the case of women of childbearing age, urine pregnancy test must be negative exclusion criteria: * patients with acute artery disease within 3 months * history of revascularization procedure or aneurism operation within 6months * patients with myopathy, rhabdomyolysis * patients with pancreatitis * patients with hiv positive * history of malignant tumor within 2 years * patients must be treated with medications prohibited for concomitant use during study period * patients with uncontrolled hypertension(sbp\>180mmhg or dbp\>110mmhg) * serum creatinine\>1.2mg/dl(female), \>1.4mg/dl(male) * ast or alt \> 2x uln * cpk \> 2x uln * patients with galactose intolerance or lapp lactase deficiency, glucose-galactose malabsorption * allergy or hypersensitive to investigational drug * history of drug or alcohol abuse within 2 years * in the case of smokers, who do not intend to non smoking * women with pregnant, breast-feeding * patients treated with any investigational drugs within 1 month at the time consents are obtained * not eligible to participate for the study at the discretion of investigator

Keywords: hyperlipidemia, familial combined omega 3 acids ethylesters 90 atorvastatin
variance of video games playing patterns among adolescents with psychiatric disorders

Conditions: ADHD; Conduct; Depression; Anxiety; PDD

Summary: as the use of video games (vg) is rapidly increasing, many studies have tries to understand the effects of vg on the children and adolescents playing them. most of the research was directed towards negative effects (especially violence, attention and school performance), producing mixed results. recently, more studies had focused their attention on the opposite angle: the influence of the player's mental and behavioral parameters, influencing his vg playing patterns. the focus of most of these researches was time of playing, addictive patterns and exposure to violence. the current study will try to characterize the variance of vg playing pattern among adolescents diagnosed with psychiatric disorders, in order to better under the rich interaction between a player and his vg, and to understand whether vg playing patterns holds diagnostical clues for the child's diagnosis and his inner world.

the participants will be asked to attend 2 session, 2 hours each, at 3-14 days interval. at the first session, after signing consent form, will asked to fill out questionaires regarding demographic data, personality, empathy trait, aggression state and trait and computer games usage. also, they will be asked to complete htp and tat psycho-diagnostic tests. then, using heart rate variability (hrv) and galvanic skin response (gsr), monitor of sympathetic tonus will be measured while playing a shooting and race game. at the end of the first session, they will be asked to fill additional aggression state questionaire. on the second session, monitored by hrv and gsr, they will be asked to play a role playing game (rpg) and real-time strategy game (rts). at the end of session, they will be asked to fill additional aggression state questionaire. parameters of playing patterns collected from the vg will be recorded and analyzed.

Eligibility criteria:
inclusion criteria: * age 13-18 * diagnosis matching one of the defined research arms, made by a childhood and adolescents psychiatry specialist * playing various computer games regularly, for at least 2 years * informed consent has been given by the minor and his parents exclusion criteria: * organic sensory depravation (blindness, deafness) * motor dysfunction, relevant of using keyboard, mouse or remote * additional psychiatric diagnosis, apart the one matching the arm to which he was allocated * using illicit drugs during the previous 48 hours

Keywords: adhd attention deficit/hyperactivity disorder conduct depression anxiety pdd pervasive developmental disorders
observational study on viral shedding and immunological response of oropouche virus

Conditions: Oropouche Infection

Summary: this is a single-center observational study, whose primary objective is to describe the immune response to oropouche virus (orov) during the study period and the duration of viral rna shedding, only for sequential samples, by rt-pcr in different matrices.

this is a study with retrospective and prospective enrollment.

Eligibility criteria:
inclusion criteria: * patients resulted positive to the rt-pcr for orov; * informed consent to the participation to the study and to personal data's treatment and/or donation of residual samples to tropika biobank; * patients ≥ 18 years old. exclusion criteria • lack of signed informed consent.
free for weaning ecmo vs respiratory driven study

Conditions: ARDS (Acute Respiratory Distress Syndrome)

Summary: in its most severe form, acute respiratory distress syndrome (ards) may require the use of veno-venous ecmo (vvecmo). while the criteria for vvecmo indication, ecmo settings, and ventilator management are relatively well-defined after the publication of the eolia trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvecmo. besides, advances in the understanding of the pathophysiology of mechanical ventilation (mv) weaning process have led to the development of specific monitoring tools for this phase. schematically, respiratory drive can be evaluated via the ventilator by measuring the pressure generated during a 100-millisecond expiratory occlusion (p0.1) and respiratory efforts through the measurement of esophageal pressure variation (delta poeso). recent retrospective studies conducted on covid-19 ards patients supported by vvecmo suggest a longer duration of mechanical ventilation for patients whose weaning and decannulation process was "forced," i.e., performed under conditions of significant respiratory drive and effort. high values of p0.1 and delta poeso were associated with prolonged mv duration. self-inflicted lung injury (p-sili) and elevated transpulmonary pressure related to these uncontrolled respiratory efforts likely explain the negative impact on mv duration. therefore, this randomized study proposes to assess these monitoring tools, which are regularly used in clinical practice, to guide vvecmo weaning and decannulation decisions.


Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or older patient whose trusted person has given consent for participation in the study * patient on veno-venous ecmo with weaning criteria, including: * resolution of the cause of ards * absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours * use of a ventilatory mode that allows spontaneous ventilation (vs-ai, bipap, or aprv) * maximum inspiratory pressure ≤ 28 cm h2o, with a maximum driving pressure ≤ 15 cm h2o, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight (pbw) * ecmo membrane sweep flow ≤ 2 l/min * patient protected by social security exclusion criteria: * contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia), * patient with treatment limitation at the time of inclusion, * patient in the time frame of exclusion from another research protocol at the time of consent signing, * vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.

Keywords: veno-venous ecmo decannulation
pilot trial in sleep laboratory setting to compare the physiology of night time bladder function in subjects with overactive bladder (oab) versus subjects that have insomnia and healthy normal subjects

Conditions: Bladder Function

Summary: this is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. no study drug will be given. all subjects will complete a one week sleep diary and a 3-day bladder diary. after one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. during the sleep night stay, subjects will be evaluated using cystometry and polysomnography. in the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.


Eligibility criteria:
inclusion criteria: * must not have a urinary tract infection * time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month * usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month * oab subjects * oab symptoms for \>= 3 months * documented detrusor overactivity episodes within 6 months * insomnia subjects * diagnosis of chronic primary insomnia * history of \> 1 month of waking up more than 2 times per night and being awake for more than 60 minutes per night for at least 3 months exclusion criteria: * diagnosis of both oab and primary insomnia * diagnosis of nocturnal polyuria * diagnosis of bph * bmi \>= 34

Keywords: oab insomnia bladder function cystometry polysomnography
brief intervention for sleep medication misuse among elderly

Conditions: Harmful Use of Hypnotic

Summary: randomized controlled trial to evaluate effectiveness of behavioral brief intervention administered by general practitioners (gps) versus business as usual on use of z-hypnotics by elderly patients in primary care.

two armed study with controlled masked first part over 6 months. active arm is with brief intervention for inappropriate use of z-hypnotics among elderly with intervention delivered by trained gps. control arm is for patients handled by their (non-trained) gps with business as usual (bau). main outcome is 6 weeks after intervention with additional data collection points after 6 months (blinded) and long-term follow-up to 12 months (open). after 6 months there will be an open single crossover as bau gps will then also receive training in the brief intervention method. baseline assessments are limited to self reports and automatic sleep assessment with actigraphy to avoid assessment effects. follow-up at main outcome time point is in person, some outcomes are also by telephone assessment and compared to baseline prior to intervention (e g actigraphy assessment.

Eligibility criteria:
inclusion criteria: * self-reported use of z-hypnotics \> 4 days per week and \> 4 weeks exclusion criteria: * diagnosis of dementia, * diagnosis of psychosis, * diagnosis of major depression, * diagnosis of delirium, * unable to give informed consent, * insufficient norwegian language capacity to complete tests

Keywords: z-hypnotics insomnia sleep side effects cognitive function pain behavioral intervention dependence quality of life
effect of face scanning on accuracy of dental implant placement in fixed implant supported maxillary prostheses

Conditions: Computer-Assisted Surgery

Summary: the study will compare the accuracy of surgical guides fabricated by two different scanning protocols; facially driven scanning versus dual scanning protocol regarding the deviation of implant placement.

twelve completely edentulous patients will be selected for full arch maxillary guided implants placement with immediately loaded restoration. the patients will make a complete oral and radiographic examination before inclusion in this study. all patients will receive maxillary and mandibular complete dentures that will be made in a conventional way. the patients will be randomly divided into two equal groups; group (i) and group (ii). in both groups two cbct scans will be made. a cbct scan will be made for each patient while wearing the radiographic stent and another cbct scan will be made for the radiographic stent alone. however, for patients in group ii a face scan will be added to previous scans. for each patient in group i, the dicom files will be exported to blue sky implant designing software (langenhagener, mdi europa gmbh), fusion of the scan prosthesis via the markers is accomplished and the ideal surgical site and optimal implant dimensions will be selected. all the surgical guides will be planned to be totally limiting in this study. the immediate provisional restoration will be planned on the software according to the previously planned implants sites. the surgical guide will be 3d printed. the approved tooth arrangement will be subsequently sent as an stl file to a milling machine. for each patient in group ii, the dicom files and the stl files obtained from the face scans will be exported to blue sky implant designing software (langenhagener, mdi europa gmbh). the facial scan will be used to define the interpupillary and midsagittal planes and to examine the tooth form and buccal corridor width with regard to the patient's smile line. both files data will be superimposed and the planning for the implants sites, surgical guide and immediate restoration will be done as in group i. after implant insertion, cbct scan will be made for each patient while wearing the scan appliance. superimposition of cbct scans pre and post implant insertion and restoration will be made. deviations between planned and placed implant will be measured in the lateral apical, lateral coronal and angular aspects. also, the patient satisfaction will be measured on a likert scale.

Eligibility criteria:
inclusion criteria: - the inclusion criteria will be completely edentulous patients, non-smokers, 50-70 years in age, have good oral hygiene and motivation. exclusion criteria: * the excluded patients will include patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, the need for extensive bone grafting in planned implant site, pregnancy, patients under bisphosphonate treatment, and limited mouth-opening for executing the guided implant surgery.

Keywords: guided implant placement- face scanning - edentulous maxilla
a study to assess the safety, tolerability and pharmacokinetics of lipovirtide in hiv-infected patients

Conditions: HIV Infections

Summary: to evaluate the safety, tolerability of single dose lipovirtide injection in hiv-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.


Eligibility criteria:
inclusion criteria: 1. male or female aged from 18 to 60 (include 18 and 60)； 2. body mass index (bmi) \[weight (kg)/ height 2(m2)\] is from 18.0 to 26.0（include 18.0 and 26.0），male weight≥50kg，female weight≥45kg； 3. confirmed hiv-1 infection； 4. hiv viral load ≥ 1000 copies/ml； 5. patients who have no birth plan within 2 weeks before the screening and 3 months after the end of the trial, consenting to take effective non-drug contraceptive measures during the trial period； 6. understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document. exclusion criteria: 1. patients in the acute infection stage; 2. confirmed aids patients； 3. patients who have received antiviral therapy and/or have been vaccinated against hiv； 4. hbsag is (+), and/or anti-hcv is (+)； 5. abnormal liver function tests (alt and / or ast\> 3uln, or total bilirubin\> 2uln)； 6. glomerular filtration rate \<70ml/min/1.73m2, or creatinine ≥uln； 7. patients who is currently suffering from a more serious chronic diseases, metabolic diseases (such as diabetes), neurological and mental diseases； 8. patients who have previous history of pancreatitis； 9. females who are pregnant or breastfeeding, or females of childbearing age who are unable to take contraception as required; 10. allergic constitution or known allergy to the components of study drug； 11. with a history of smoking addiction within 12 months before screening (average number≥5 cigarettes per day)； 12. with a history of alcohol abuse within 12 months before screening (average drinking≥14 units of alcohol per week: 1 unit = 285ml beer, 25ml spirits, or 150ml wine) or those who have a positive alcohol breath test before enrollment； 13. with a history of drug abuse within 12 months before screening or those who tested positive for addictive substances before enrollment； 14. patients who have participated in other investigational drug study within 3 months before screening (except for traditional chinese medicine）； 15. other factors that the investigators consider unsuitable for the trial.
hydroxychloroquine chemoprophylaxis in healthcare personnel in contact with covid-19 patients (phydra trial)

Conditions: COVID-19; Severe Acute Respiratory Syndrome

Summary: triple blinded, phase iii randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to covid-19 patients.

healthcare personnel infection with covid-19 is a major setback in epidemiological emergencies. hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo effects. nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. since there is currently no treatment for covid-19 exposure prophylaxis, the investigators will implement a triple blinded, phase iii randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.

Eligibility criteria:
inclusion criteria: * 18 years old upon study start * healthcare personnel exposed to patients with covid-19 respiratory disease: physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists. * signed consent for randomization to any study arm. exclusion criteria: * known hypersensitivity to hydroxychloroquine manifested as anaphylaxis * current treatment to chloroquine or hydroxychloroquine * women with last menstruation date farther than a month without negative pregnancy test. * women with positive pregnancy test * breastfeeding women * chronic hepatic disease history (child-pugh b or c) * chronic renal disease (gfr less or equal to 30)